The present invention is directed toward a percutaneous gastrostomy device and toward a method for installing a gastrostomy device within a patient.
Several different gastrostomy device designs have been developed and employed over the years. Each of these designs has met with varying degrees of success. U.S. Pat. No. 5,007,900, the disclosure of which is expressly incorporated herein in its entirety, discloses one type of gastrostomy device that has been well received in recent years. The '900 device includes a resilient tube having a distal end with a resilient retainer. The retainer has a pocket radially spaced from the tube and adapted to receive a rod and permit proper orientation of the retainer. More specifically, the rod urges the retainer to a stretched position collateral with the tube to facilitate installation of the gastrostomy device within a patient.
U.S. Pat. Nos. 4,311,148 and 4,668,225 show feeding tubes or catheters having resilient wing-like protrusions about the end of the tube for retaining the tubes within a passage through the wall of a body cavity. The tubes are designed to be inserted into the patient through fresh incisions that are then sutured about the tube. To remove these tubes from the cavity, it is possible to pull the end through the passage while exerting sufficient force to fold the wings back out of the way.
U.S. Pat. No. 4,573,576 shows a catheter with a disk-like retainer on one end. A line is introduced through an incision in the patient's skin, fascia and stomach wall, and an endoscope is used to capture the loose end within the stomach and to draw it out the patient's mouth. The line is then used to draw the tube portion of the catheter out through the incision. An endoscope is also used to remove the catheter.
After an incision establishes a passage through the body wall and a tube is passed therethrough, over a period of time, the body heals to a degree about the tube thereby forming a stoma. The passage or stoma becomes relatively stable, much like the hole for pierced ears, for example. Without the tube, the stoma would eventually close up, but in the meantime, a well-defined passage exists, even if the tube is withdrawn.
This well-defined passage is suitable for the external percutaneous insertion of appropriately designed catheters. However, none of the aforementioned gastrostomy devices are suitable for this purpose, largely because of the difficulty in pushing a flexible tube, versus pulling it, and also because the folded-over wings make a poor dilator for the passage.
U.S. Pat. No. 4,863,438, which is included herein in its entirety by reference, shows a catheter that may be inserted into the stoma from outside the body. A hollow mushroom-shaped resilient head on the tube may be distended by the insertion of a rigid obturator into the tube, the distended head acting as a dilator small enough to pass through the stoma. Once the head clears the stoma, the obturator is withdrawn, and the head expands. A similar process is employed to remove this device, or mechanical traction may be used to remove the device.
U.S. Pat. No. 5,405,378, the disclosure of which is expressly incorporated herein in its entirety, discloses a flexible probe and a tubular element that fits over the probe. The tubular element is retained by a filament wound around the outer periphery of the element. The tubular element is retained on the outer periphery of the probe in a radially-impressed state. Upon appropriate placement of the element in a blood vessel, the filament is pulled to release the element and enable the element to expand into place.
The known methods and devices for placement of gastrostomy tubes require several steps and significant difficulty for the surgeon, thereby increasing the time and expense of the procedure. Therefore, there exists a need in the art for a gastrostomy tube which is easily installed, and definitely secured to the patient.